Data as of 2026-07-12 — 788,886 rows loaded

050767

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CLEOCIN CLINDAMYCIN PHOSPHATE SUPPOSITORY;VAGINAL 100MG Prescription ✓ ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 19 AP 2022-07-26 LABELING STANDARD
SUPPL 18 AP 2022-05-17 LABELING STANDARD
SUPPL 17 AP 2020-03-23 LABELING STANDARD
SUPPL 16 AP 2019-09-16 LABELING STANDARD
SUPPL 15 AP 2018-12-20 LABELING STANDARD
SUPPL 14 AP 2017-09-08 LABELING STANDARD
SUPPL 12 AP 2015-07-13 LABELING STANDARD
SUPPL 11 AP 2014-05-09 LABELING STANDARD
SUPPL 10 AP 2013-06-19 LABELING STANDARD
SUPPL 1 AP 2000-05-15 MANUF (CMC) STANDARD
ORIG 1 AP 1999-08-13 TYPE 3 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2022-08-05 Label SUPPL-19 0
2022-07-27 Letter SUPPL-19 0
2022-05-19 Label SUPPL-18 0
2022-05-18 Letter SUPPL-18 0
2020-03-24 Label SUPPL-17 0
2020-03-24 Letter SUPPL-17 0
2019-09-18 Label SUPPL-16 0
2019-09-17 Letter SUPPL-16 0
2018-12-21 Label SUPPL-15 0
2017-09-15 Letter SUPPL-14 0
2017-09-11 Label SUPPL-14 0
2015-07-16 Label SUPPL-12 0
2015-07-15 Letter SUPPL-12 0
2014-05-12 Letter SUPPL-11 0
2014-05-12 Label SUPPL-11 0
2013-06-26 Label SUPPL-10 0
2013-06-20 Letter SUPPL-10 0
1999-08-13 Label ORIG-1 0
1999-08-13 Letter ORIG-1 0
1999-08-13 Review ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050767", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "17"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "19", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "15", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "050767", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "050767", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "050767", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "050767", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "050767"}